NCT06666881 Skeletal Muscle Mass Changes on Images for Prediction of Prognosis After Exercise Training in HNSCC Patients
| NCT ID | NCT06666881 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chang Gung Memorial Hospital |
| Condition | Head and Neck Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-06-06 |
| Primary Completion | 2025-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2023-06-06 with a primary completion date of 2025-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This project adopts a prospective study design. It is scheduled to enroll 60 participants diagnosed with Head and Neck cancer in this hospital, of which 30 are in the experimental group and 30 are in the control group. The purpose of this research is to analyze the skeletal muscle mass changes on images in Head and Neck cancer patients after exercise training and the association with systemic inflammatory markers. Investigators would like to know whether these images and biomarkers predict the prognosis of Head and Neck cancer. Subjects enrolled in the trial will receive 36 times of exercise training after concurrent chemoradiotherapy. Before and after the completion of exercise training, investigators will arrange (1) dual energy X-ray absorptiometry (DXA) to measure the whole-body skeletal muscle mass and appendicular skeletal muscle mass and (2) blood tests for markers of systemic inflammation. In addition to DXA, computed tomography (CT) is another image modality for skeletal muscle mass evaluation. Positron emission tomography - CT or whole-body CT for cancer staging are considered as baseline studies. The routine follow-up CT images are used to analyze the changes after exercise training. If magnetic resonance imaging is also performed during the follow-up period, images will also be collected and assessed as an alternative.If the experimental group can maintain or even improve skeletal muscle mass and can be reflected in blood tests and prognosis, the result may be able to apply on cancer treatment and disease followup.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥20 2. Pathology:Squamous cell carcinoma 3. Need CCRT treatment 4. ECOG PS\<2 5. Agree with blood drawing, exercise training, and all the procedures in the trial. Exclusion Criteria: 1. ECOG PS≥2 2. Participants with intolerance basic exercise training, or without CCRT treatment 3. Mental illness or any medical illness or concurrent illness that may be aggravated by exercise training or unmanageable 4. Any medical condition that unsuitable for exercise training 5. refure to do the trial procedures: exercise training, blood drawing and all the procedures in the trial. 6. can't get the data for the whole-body computed tomography
Contact & Investigator
Shao-Chung Wang
STUDY DIRECTOR
New Taipei City TuCheng Hospital
Frequently Asked Questions
Who can join the NCT06666881 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 80 Years, studying Head and Neck Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06666881 currently recruiting?
Yes, NCT06666881 is actively recruiting participants. Contact the research team at seanscwang@cgmh.org.tw for enrollment information.
Where is the NCT06666881 trial being conducted?
This trial is being conducted at New Taipei City, Taiwan.
Who is sponsoring the NCT06666881 clinical trial?
NCT06666881 is sponsored by Chang Gung Memorial Hospital. The principal investigator is Shao-Chung Wang at New Taipei City TuCheng Hospital. The trial plans to enroll 60 participants.
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